Safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (liver disease) from nonalcoholic steatohepatitis (NASH).

Phase 1

• Conditions: Compensated Cirrhosis from Nonalcoholic Steatohepatitis (NASH); MedDRA version: 20.1Level: LLTClassification code 10064844Term: Compensated cirrhosisSystem Organ Class: 100000004871; MedDRA version: 20.0Level: HLTClassification code 10019669Term: Hepatic fibrosis and cirrhosisSystem Organ Class: 100000004871; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-003932-22-IT
• Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-04
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

- Participants with liver biopsy fibrosis score stage 4 performed within 6 months
- Men and women must agree to follow methods of contraception
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 189
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 81

Exclusion Criteria

- Worsening liver disease or any disease might compromise participant safety in the opinion of the investigator;
- Known immunocompromised status or any disease or condition which might compromise participant safety;
- Prior exposure to BMS-986263
- Clinically relevant abnormal physical examination, vital signs, ECG, or clinical laboratory tests;
- Hepatic decompensation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: _To evaluate the efficacy of BMS-986263 compared with placebo to improve liver fibrosis in participants with compensated cirrhosis due to NASH;Secondary Objective: _To further assess the efficacy of BMS-986263 compared with placebo to improve liver fibrosis, as determined by liver biopsy, in participants with compensated cirrhosis due to NASH;<br>_To assess the safety and tolerability of BMS-986263 in participants with compensated cirrhosis due to NASH;<br>_To assess the PK of BMS-986263 in participants with compensated cirrhosis due to NASH;Primary end point(s): Proportion of participants who achieve = 1 stage improvement in liver fibrosis (NASH CRN Fibrosis Score), as determined by liver biopsy after 12 weeks of treatment;;Timepoint(s) of evaluation of this end point: after 12 weeks of treatment